Plain English Summary

Background and study aims The aim of this study is to monitor the performance of on-market (CE marked) blood glucose monitoring systems (blood glucose meters and test strips) designed for people with diabetes to test their blood glucose, especially those people who take insulin. These systems are used as part of standard care of diabetes and are freely available to buy on the market.

Who can participate? Patients over 16 years of age with diabetes who are willing to provide a blood sample for analysis.

What does the study involve? You will visit a diabetes clinic or suitable outpatient clinic. The visit is expected to last about 5 to 20 minutes. You will give a blood sample either by venepuncture (the puncture of a vein) or by a fingerprick and the blood will be tested using both the blood glucose monitoring system and the reference method.

What are the possible benefits and risks of participating? There may be no direct benefit to the subject if they decide to take part in this study. However, the information gained from the results will make an important contribution to ensuring the blood glucose monitoring systems give reliable results for people with diabetes. The risks to taking part in this study are the same as those associated with routine self-blood glucose testing or giving a blood sample. These risks are small but could include pain, bruising, local infection and fainting caused by the lancet or needle used to obtain a blood sample.

Where is the study run from? The Diabetes Centre, Ipswich Hospital NHS Trust (UK).

When is the study starting and how long is it expected to run for? The study started in October 2014 and will finish in October 2024.

Trial website

Contact information

Type

Primary contact

ORCID ID

Contact details

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ADC-PMS-GLU-12014

Study information

Scientific title

Blood glucose performance test

Acronym

NA

Study hypothesis

This aim of this study is to evaluate the accuracy of blood glucose monitoring systems on subjects with diabetes at the study site. The results will be evaluated by comparing results obtained using either venous whole blood obtained by venepuncture or capillary whole blood obtained from a fingerstick and then tested on the blood glucose monitoring system, to whole blood tested on the Yellow Spring Instrument (YSI analyser) reference method.

Ethics approval

Study design

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Condition

Diabetes

Intervention

Either:Venepuncture will be performed and venous whole blood from the subject will be tested on the blood glucose monitoring system, the HemoCue analyser and the YSI analyser as whole bloodOr:A fingerstick will be performed and capillary whole blood from the subject will be tested on the blood glucose monitoring system. The same fingerstick will be used to collect a blood sample to perform measurements on the HemoCue analyser and the YSI analyser as whole blood

Intervention type

Device

Phase

Drug names

Primary outcome measure

The accuracy of the blood glucose monitoring system compared to the YSI analyser using fingerstick capillary or venous whole blood samples

Secondary outcome measures

N/A

Overall trial start date

29/10/2014

Overall trial end date

31/10/2024

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Subjects has diabetes2. Subject is willing to provide a whole blood sample for analysis using:2.1. The blood glucose monitoring systems2.2. HemoCue analyser2.3. YSI analyser3. The subject is able to understand the patient information sheet and sign the informed consent form prior to any clinical investigation plan directed activity

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50 per study event

Participant exclusion criteria

1. Subject under 16 years of age2. Subject is unwilling or unable to give consent for a blood sample to be collected